Drugs@FDA: FDA-Approved Drugs
Company: SPECGX LLC
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.2MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.4MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 0.8MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.2MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
FENTANYL CITRATE | FENTANYL CITRATE | EQ 1.6MG BASE | TROCHE/LOZENGE;TRANSMUCOSAL | Discontinued | None | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
10/30/2009 | ORIG-1 | Approval |
Letter (PDF)
|
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2009/078907s000ltr.pdf |
Supplements
Action Date | Submission | Supplement Categories or Approval Type | Letters, Reviews, Labels, Patient Package Insert | Note | Url |
---|---|---|---|---|---|
12/08/2022 | SUPPL-25 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
08/17/2022 | SUPPL-24 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
12/03/2021 | SUPPL-22 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
12/23/2020 | SUPPL-17 | REMS - MODIFIED - D-N-A |
Label is not available on this site. |
||
09/07/2017 | SUPPL-16 | REMS-Modified |
Label is not available on this site. |
||
04/24/2017 | SUPPL-15 | Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
||
12/24/2014 | SUPPL-12 | REMS-Modified |
Label is not available on this site. |
||
11/07/2013 | SUPPL-11 | REMS-Modified |
Label is not available on this site. |
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06/08/2012 | SUPPL-9 | Labeling-Package Insert |
Label is not available on this site. |
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01/04/2012 | SUPPL-8 | Labeling-Container/Carton Labels, Labeling-Medication Guide, Labeling-Package Insert |
Label is not available on this site. |
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01/04/2012 | SUPPL-7 | REMS-Proposal |
Label is not available on this site. |